Larynx mask having a connector

ABSTRACT

The invention relates to a larynx mask comprising a dorsal cover plate with an inflatable cuff integrally formed thereon and a tube connecting connector to a plug region having an adjoining insertion section for connecting to an insertion tube. Two separate lumens are provided in the region of the insertion section, these being the esophageal lumen and a respiration lumen. Said two lumens are separated from each other by a separating or supporting wall. Said separating or supporting wall runs from the insertion section to the tip of the larynx mask. While the esophageal lumen opens into the esophageal outlet at the proximal end, the respiration lumen opens in the ventral direction, while the lumen is closed in the proximal direction close to the tip. Such a larynx mask can be produced in one piece by way of injection molding and at the same time is reinforced by the separating or supporting wall to prevent kinking.

The present invention relates to a larynx mask, comprising a dorsalcover plate with an inflatable cuff (5) circumferentially formed thereonand a tube connecting connector for connecting to at least one insertiontube which comprises an air supply lumen and an oesophageal lumen,whereby the tube connecting connection has an insertion section.

Larynx masks of this type are known in many forms of embodiment and areinserted by means of a tube, known as a supraglottic tube, through themiddle of the pharynx via the epiglottis of an anaesthetised patient.Larynx masks are usually supplied as a unit with the supraglottic tubeformed on or attached thereto. This serves to keep open the airways andto ventilate a patient. At the same time such larynx masks also allowthe introduction of tubes, probes, optical instruments and otherinstruments into the respiratory tract. More and more frequently suchlarynx masks have an oesophageal access. This allows the introduction oftubes into the oesophagus and the stomach in order to remove gastricjuice and other fluids as well as air from the stomach. In anaesthetisedpatients emptying of the stomach is intended to prevent the stomachcontents flowing back into the upper respiratory tract and beingaspirated into the unprotected airways (windpipe, bronchi and lungs). Afurther advantage of an oesophageal access is the removal of passivelyor actively regurgitated stomach contents from the upper oesophagus tooutside, which thereby represents limited, and thus inadequate,aspiration protection.

A large number of different larynx masks are known on the market. Atypical example is set out in U.S. Pat. No. 5,878,745. This shows agastro-laryngeal mask in which the supraglottic tube is a pipe throughwhich several tubes can be fed. These tubes have lumens which are usedfor ventilation and for an oesophageal access. As a tube the oesophagealaccess must be passed through the entire larynx mask, fastened andpassed through an outlet passing through the cuff. This is extremelytime-consuming and requires a great deal of work.

Inserting a larynx mask is not always easy. Larynx marks with arelatively rigid supraglottic tube can be introduced more easily,whereby the rigidity prevents adaptation of the position of the larynxmask to the anatomical conditions. Insertion into the pharyngeal cavityby means of a relatively rigid supraglottic tube can result in injury,and positioning in the pharyngeal cavity is not always reliable.

Highly flexible larynx masks with corresponding highly flexiblesupraglottic tubes allow better positioning in the larynx but are moredifficult and therefore occasionally more traumatic to insert and moredifficult to position in the pharynx. More particularly, if oftenhappens that when inserting such highly flexible larynx masks theproximal end of the larynx mask, known as the tip, is bent over. Thismeans that reliable sealing of the larynx mask is no longer present. Toremedy this problem a more rigid material can be resorted to, whereby,however, the advantages of the highly flexible materials are lost. Theresult is traumatic effects in the central pharyngeal cavity. Even witha slightly increased air pressure in the cuff this problem cannot alwaysreliably be solved. In the larynx masks known today, the oesophagealoutlet always passes through the cuff. This complicates the entiremanufacturing of the larynx mask. If kinking or even just slightlygreater bending of the tip of the larynx mask occurs the oesophagealoutlet is mostly then no longer free and an instrument or a tube can nolonger be passed through.

A larynx mask is known from U.S. Pat. No. 5,878,745 in which the larynxmask itself is made more rigid by passing through an oesophageal accessin the longitudinal direction. This oesophageal access is placed in thecentre. Although this increases the longitudinal rigidity of the larynxmask it unfavourably affects its height. Also, the patient's pharynxmust be protected by means of an additional inflatable dorsal cuff.

From WO 2006/125986 and US 2003/0037790 different versions of larynxmasks are known in which the oesophageal access is formed either by aseparately insertable tube or by an integrally formed lumen. In bothcases, however, the course of the oesophageal opening in the midlongitudinal axis has the aforementioned disadvantages.

A presumably not manufacturable larynx mask is shown by a solution inwhich the insertion tube runs from outside the patient continuously tothe tip of the oesophageal outlet and two integral cuffs are present onthe one hand to delimit the respiration chamber and on the other hand toseal the oesophageal outlet.

It is therefore the dual aim of the present invention, in addition toavoiding the described drawbacks of the prior art, to improve a larynxmask in such a way that it is easier to produce and, more particularly,so that difficult insertion of a tube for forming the oesophagealpassage can be avoided, and that even with the use of a highly flexiblematerial said problems no longer occur, or their occurrence is greatlyreduced.

This aim is achieved by a larynx mask in accordance with theintroductory section of claim 1 which is characterised in that the tubeconnecting connector after an insertion section has a separating orsupporting wall running in the longitudinal direction of the larynx maskfrom its distal to at least approximately its proximal end andseparating a closed lumen as the oesophageal lumen and an open lumen asa respiration lumen, which opens into a respiration space under thecover plate which can be sealed by the cuff.

Overall the longitudinal division in accordance with the invention ofthe area of the larynx mask below the cover plate by way of separatingand supporting wall brings about a strengthening of the larynx maskagainst kinking, whereby the first part of the task is achieved, whileat the same time, as the separating wall is part of a continuous closedlumen, serving as the oesophageal lumen, the entire manufacture of thelarynx mask is considerably simplified with regard to its assembly. Thusit is no longer necessary for a separate tube to be pulled through thelarynx mask and attached therein, but the oesophageal lumen is formed inone piece with the larynx mask. Due the straight course and conicalnarrowing of the oesophageal opening from the tube connecting connectionwith the largest diameter to the outlet opening defining the smallestdiameter, by means of a simple slide such an opening can be manufacturedin one piece.

In the drawings a preferred example of embodiment of the subject matterof the invention is shown and is explained with the aid of the followingdescription.

FIG. 1 shows a perspective overall view of a larynx mask in accordancewith the invention looking at the dorsal cover plate, while

FIG. 2 again shows a perspective overall view of the same larynx mask,but looking at the ventrally arranged cuff.

FIG. 3 shows a vertical view of the larynx mask on the ventral side and

FIG. 4 shows a longitudinal section through the larynx mask in thedirection of the course of the oesophageal lumen.

FIG. 5 shows a cross-section through the larynx mask in the area of aninsertion section looking towards the proximal end and the oesophagealoutlet 6.

FIG. 6 again shows a cross-section through the same larynx mask in thecentral area of the longitudinal extent of the larynx mask whereby thedirection of viewing is again towards the proximal end, while

FIG. 7 shows the same cross-section at the same point, but lookingtowards the distal end of the larynx mask.

FIG. 1 shows the larynx mask which is denoted overall with 1. Aninsertion tube is attached to this larynx mask but is not shown in thedrawing. However, for this a tube connecting connector 2 is used. Thistube connecting connector 2 transits into a cover plate 3 and cuff 5also formed thereon in one piece. The entire larynx mask 1 from the tubeconnecting connection 2 on the distal end to the tip 4 on the proximalend of the larynx mask is produced in one piece and accordingly all ofthe same synthetic material. In the view in accordance with FIG. 1 thecircumferential cuff 5 can be seen which only on the proximal end at thetip 4 is reduced in diameter by an oesophageal outlet 6 whereas at thedistal end the cuff 5 passes through under the tube connectingconnection 2. At the proximal end the oesophageal outlet 6 passes overthe cuff 5 in a type of channel.

The cuff 5 is produced by open injection moulding. In particular, in thecross-section drawings 6 and 7, but also in the view in accordance withFIG. 2, a circumferential thickened adhesive, welding wall 13,practically following the peripheral edge of the cover 3, can be seen,while at the same time the lower edge of the cuff 5, here still shown asopen, is also provided with a circumferential adhesive, welding edge 15.Only through adhering or welding the adhesive, welding edge 15 to thecorresponding circumferential adhesive, welding wall 13 is the closedcircumferential cuff 5 produced. This cuff 5 inflated and deflated via aventilation connection 8 which is on the ventral side of the tubeconnecting connection 2. This ventilation connection 8 can be clearlyseen in FIG. 2-4.

The circumferential adhesive or welding wall 13 delimits a respirationchamber 7 below the cover plate 3.

As has already been stated an insertion tube, which is not shown here,is introduced into the tube connecting connection 2. This insertion tubeadvantageously, but not necessarily, consists of a single plastic tubewith two lumens which in terms of shape and size are matched to thelumens present in the larynx mask. To make this connection of the larynxmask to the insertion tube as simple as possible, the tube connectingconnection 2 has a plug section 16 which can be seen in particular inFIGS. 2 and 4. The plug section 16 is not divided into two lumens, aspreferably an insertion tube is insert here which has two lumens in thesame form as in the insertion section 12 following on from the plugsection 16. This insertion section 12 runs at least approximately underthe area in which the two lumens 10 and 11 extend over the cuff 5.Although in FIG. 4 it appears as if these areas pass under the cuff 5,this is only due to illustration in which the ventral side is shownfacing upwards instead of the dorsal side.

Following the plug section 16 of the tube connecting connection 2 thereis, as has been stated, an insertion section 12. In this area twoseparate lumens can be seen which are both closed in this area, namelythe oesophageal lumen 10 and the respiration lumen 11. This is mostclearly seen in FIG. 5. Running between these two lumens 10 and 11 atleast approximately perpendicularly to the cover 3 is a separating andsupporting wall 9. Through this separating and supporting wall whichpasses through the larynx mask in around the middle, the larynx mask isprovided overall with increased rigidity which counteracts any kinking.

In an advantageous embodiment the separating and supporting wall 9 canhave a sack-like intermediate chamber which is closed until near to thetip and which can accommodate a reinforcing element.

The thickened adhesive, welding wall 13, which is not in cross-sectionin FIG. 5, increases the rigidity of the larynx mask. It can be clearlyseen that the cuff it not yet closed by welding or adhesion andaccordingly the adhesive and/or welding edges 15 can be seen.

After the end of the insertion section 12 the oesophageal lumen 10continues to be closed, while the respiration lumen 11 opens into apractically U-shaped channel as can be clearly seen in FIGS. 6 and 7.Both figures show the same cross-section at the same point, but in FIG.6 the view is directed towards the distal end. The separating andsupporting wall 9 remains unchanged through the absence of the ventralwall section of the respiration lumen 11. In these figures it can alsobe seen that the diameter of the two lumens, namely the oesophageallumen 10 and the respiration lumen 11, and therefore also the separatingand supporting wall 9 runs downwards from the cover plate 3 in theventral direction less far from the cover plate 3 than thecircumferential adhesive or welding wall 13. The end of this adhesive orwelding wall 13 spans a plane and this plane is neither pierced by thetwo lumens 10 and 11 nor by the wall 9. In this way a relatively largerespiration chamber 7 remains under the two lumens 10 and 11 and theseparating and supporting wall 9. It can be seen that after theinsertion section 12 from where the respiration lumen 11 opens out thisspace directly merges with the respiration chamber 7. In FIG. 6 whichshows the diametric section through the larynx mask looking towards theproximal end, it can be seen that the oesophageal lumen 10 is opentowards the oesophageal outlet 6, while the respiration lumen 11 islimited in the proximal direction by the adhesive or welding wall 13.

As has already been stated the insertion tube is not shown here.Preferably, in cross-section such an insertion tube will be shaped likethe tube connecting connector 2 in the cross-section area in accordancewith FIG. 5. However, this is not obligatory. For example, an adapter,into which two individual tubes open which together form an insertiontube 2, can be inserted into the plug areas 16 up to the projection 14.

LIST OF REFERENCE NUMBERS

-   1. Larynx mask-   2. Tune connecting connection-   3. Cover plate-   4. Tip of the larynx mask-   5. Cuff-   6. Oesophageal outlet-   7. Respiration chamber-   8. Cuff ventilation connection-   9. Separating and supporting wall-   10. Oesophageal lumen-   11. Respiration lumen-   12. Insertion section-   13. Adhesive, welding wall-   14. Projection-   15. Adhesive, welding edge-   16. Plug area

1. A larynx mask comprising a dorsal cover plate with a circumferentialinflatable cuff formed thereon and a tube connecting connector forconnecting to at least one insertion tube, which comprises an air supplylumen and an oesophageal lumen, whereby the tube connecting connectorhas an insertion section, wherein there is a separating and supportingwall running from dorsal to ventral, which is formed at leastapproximately centrally on the cover plan and runs in a longitudinaldirection of the larynx mask passing through it from distal to at leastapproximately its dorsal end and forming the partition between a closedlumen as the oesophageal lumen and an open lumen as a respiration lumen,which opens out into a respiration chamber which can be sealed under thecover plate by the cuff.
 2. The larynx mask of claim 1 wherein thecross-section of the respiration lumen is larger than the cross-sectionof the oesophageal lumen in the opening area of the insertionconnection.
 3. The larynx mask of claim 1, wherein the cross-section ofthe respiration lumen is smaller than the cross-section of theoesophageal lumen in the opening area of the tube connecting connector.4. The larynx mask of claim 1 wherein the separating and supporting wallof the larynx mask runs perpendicularly to the cover plate.
 5. Thelarynx mask of claim 1 wherein at the proximal end of the larynx maskthe separating and supporting well runs to the oesophageal outlet whichis formed by an opening in the cover plate so that the oesophagealoutlet extends above it over the cuff.
 6. The larynx mask of claim 1wherein the insertion section is limited by a projection narrowing thecross-section and serving as a stop for the insertion tube to beinserted.
 7. The larynx mask of claim 1 wherein the respiration chamberis delimited by a circumferential adhesive or welding edge which runsfrom the cover plate to the cuff.
 8. The larynx mask of claim 7 whereinthe separating and supporting well extends from the cover plate tomaximally down into the plane spanned by the circumferential adhesive orwelding wall.
 9. The larynx mask of claim 1 wherein the separating andsupporting wall has a proximally closed, sack-like intermediate spacefor accommodating a reinforcing element.